PATIENT-REPORTED OUTCOMES IN LABELS AND PACKAGE LEAFLETS OF DRUGS APPROVED BY THE EUROPEAN MEDICINES AGENCY FROM 2007 TO 2017
Author(s)
Holm SP1, Fuchsberger M1, Bowden G2, Buisson S1
1Excerpta Medica, Amsterdam, The Netherlands, 2Excerpta Medica, London, UK
OBJECTIVES: The patient perspective is becoming increasingly important to prescribing decision-making. Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have published guidance on the use and inclusion of patient-reported outcome (PRO) data in product labelling. The objective of this study was to investigate PRO claims cited in the Summaries of Product Characteristics (SmPCs) and package leaflets of products approved by the EMA over the past decade. METHODS: We reviewed the SmPCs and package leaflets of branded drugs (including orphan drugs and biosimilars) approved by the EMA from January 2007 to May 2017 in five disease areas defined using the following key criteria: diabetes, mental health, rheumatic diseases, psoriasis, and breast neoplasms. RESULTS: We identified 125 branded drugs approved in the time period studied: 54 for diabetes, 32 for mental health, 18 for rheumatic diseases, 13 for psoriasis, and 8 for breast neoplasm treatment. PRO data were cited in 3.7%, 56.3%, 77.8%, 69.2%, and 75.0% of SmPCs in each disease area, respectively. Package leaflets were typically devoid of PRO data: only 3 leaflets containing this information were identified, all in the rheumatic disease category. We did not observe an increase or decrease in PRO reporting over time. CONCLUSIONS: With respect to the EMA guidance, PRO data are still unavailable in many of the SmPCs and package leaflets of products for the treatment of diseases known to severely affect patient daily life, especially diabetes. Pharmaceutical companies should ensure that this information, if available, is included so that health care providers and decision makers are better equipped when making treatment decisions.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP169
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Multiple Diseases